• Reference Number: HEY-892/2022
• Departments: Pharmacy
• Last Updated: 1 June 2022

Introduction

This leaflet offers more information about your medicines for your medical conditions and our plans to switch your treatment over from Enbrel to Benepali. If you have any further questions or concerns after reading this leaflet, please speak to your doctor or the nurses at the Rheumatology or Dermatology Departments.

Why am I receiving this leaflet?

You may be aware that the patent for Enbrel has expired and several biosimilars have been approved and are available to patients. The biosimilar drug for etanercept (Enbrel) used at this hospital is marketed under the trade name Benepali. Since Benepali offers cost savings and enables us to deliver care more effectively, we aim to gradually switch all patients currently using Enbrel over to Benepali. 

What does this mean for me?

As Benepali and Enbrel contain the same active product (etanercept), treatment for your medical condition remains unchanged. You will receive Benepali from your next delivery date. No additional monitoring is needed.

What are biological medicines (biologics)?

Biologics are drugs that mimic or block natural chemicals in your body. They are manufactured by the pharmaceutical industry in a complex process, which involves producing the molecule and then purifying and cleaning it. Etanercept works by stopping the naturally occurring chemical, called TNF (tumour necrosis factor), from binding to cells that cause inflammation.

Biologics are extensively used in the treatment of inflammatory diseases such as rheumatoid arthritis, axial spondyloarthropathy, psoriatic arthritis, psoriasis, Crohn’s disease and ulcerative colitis. 

What is a biosimilar?

The World Health Organization (WHO) has defined a biosimilar as a drug that is similar in terms of quality, safety and effectiveness to the original licensed product. This means that biosimilars (such as Benepali) are allowed to have small structural differences from the original licensed product (Enbrel) but this must not alter how well the drug works, how safe it is, or how the drug reacts with the body’s immune system.

The process for manufacturing Enbrel, the original etanercept, has itself altered several times since it was first introduced resulting in a cleaner drug with fewer side effects. Benepali has been assessed against the last versions of Enbrel.

Biosimilars are regulated in a similar way to the original licensed product. The European Medicines Agency has approved the use of Benepali as it has been shown to be as safe and as effective as Enbrel.

Do biosimilars work as well?

There have been a number of research studies comparing how well biosimilars work and their safety. There appear to be no differences between the original biologics and the new biosimilars. Over the years, experience with biosimilars of other drugs has been acquired in this hospital and we have no new issues reported. We expect patients switching to a biosimilar to have the same response as if they had stayed on the original biologic. Unfortunately, all drugs may stop being effective at some point in time, but this is no more likely to happen with Benepali than it is with Enbrel.

Are biosimilars safe?

Biosimilars have a similar safety profile to the original biologics. The regulator of new drugs, the European Medicines Agency, has declared biosimilar drugs safe and interchangeable with the original drugs. National Institute for Clinical Excellence and Care (NICE) has also supported this position.

What happens if I change to a biosimilar but I have side effects?

Please be assured that we would not be offering this alternative medicine unless we were completely confident that it was just as safe and effective as your current medication. When switching to a biosimilar it is not expected that there will be any issues. However if you do develop a side effect you will be informed of the process which is in place to manage any complications and dealt with promptly. Information on side effects for etanercept can be found in patient information leaflet that is supplied with both Enbrel and Benepali).

Contact us

If you have any further questions, please contact the:

• Rheumatology Nursing Team Advice Line: (01482) 608779; Mon 11am – 3pm, Tue 8am – 10am, Wed 1pm – 4pm and Fri 9am – 11am
• Dermatology Nursing Team: (01482) 622484/624093

Additional services and information

• NHS Choices: NHS Choices provides online information and guidance on all aspects of health and healthcare, to help you make decisions about your health.
• Web: www.nhs.uk
• NHS 111: You can call 111 when you need medical help fast but it’s not a 999 emergency. NHS 111 is available 24 hours a day, 365 days a year. Calls are free from landlines and mobile phones

This leaflet was produced by the Pharmacy Department, Hull and East Yorkshire Hospitals NHS Trust June 2017.

Last review date: June 2022, next review date: June 2024

General Advice and Consent

Most of your questions should have been answered by this leaflet, but remember that this is only a starting point for discussion with the healthcare team.

Consent to treatment

Before any doctor, nurse or therapist examines or treats you, they must seek your consent or permission. In order to make a decision, you need to have information from health professionals about the treatment or investigation which is being offered to you. You should always ask them more questions if you do not understand or if you want more information.

The information you receive should be about your condition, the alternatives available to you, and whether it carries risks as well as the benefits. What is important is that your consent is genuine or valid. That means:

• you must be able to give your consent
• you must be given enough information to enable you to make a decision
• you must be acting under your own free will and not under the strong influence of another person

Information about you

We collect and use your information to provide you with care and treatment. As part of your care, information about you will be shared between members of a healthcare team, some of whom you may not meet. Your information may also be used to help train staff, to check the quality of our care, to manage and plan the health service, and to help with research. Wherever possible we use anonymous data.

We may pass on relevant information to other health organisations that provide you with care. All information is treated as strictly confidential and is not given to anyone who does not need it. If you have any concerns please ask your doctor, or the person caring for you.

Under the General Data Protection Regulation and the Data Protection Act 2018 we are responsible for maintaining the confidentiality of any information we hold about you. For further information visit the following page: Confidential Information about You.

If you or your carer needs information about your health and wellbeing and about your care and treatment in a different format, such as large print, braille or audio, due to disability, impairment or sensory loss, please advise a member of staff and this can be arranged.